Phase 2
N=97
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03911271 ↗Enrolled (actual)
97
Serious AEs
3.1%
Results posted
Jun 2025
Primary outcome: Primary: Axial Length at 36 Months — 25.28; 25.25; 25.33 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.1% atropine and 0.01% atropine (Drug); 0.01% atropine (Drug); 0.9% Sodium-chloride (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Line Kessel
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Length at 36 Months |
25.28; 25.25; 25.33 | — |
| PRIMARY Spherical Equivalent at 36 Months |
-4.45; -4.26; -4.43 | — |
| SECONDARY Adverse Events |
104; 22; 18 | — |
| SECONDARY Change in Choroidal Thickness From Baseline to 36 Months |
2; 7; 3 | — |
Summary
Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.
Eligibility Criteria
Inclusion Criteria
- Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye
- Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
- Cylinder less than 1.5 diopters
Exclusion Criteria
- Myopia related to retinal dystrophies
- Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
- Other ocular pathology (e.g., amblyopia, strabismus)
- Previous eye surgery
- Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
- Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
- Non-compliance to eye examinations
- Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays
Data sourced from ClinicalTrials.gov (NCT03911271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.